Events

Recall of Care Cliner

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Winco, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    56844
  • Event Risk Class
    Class 2
  • Event Number
    Z-0147-2011
  • Event Initiated Date
    2010-09-07
  • Event Date Posted
    2010-10-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-05-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94620
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Chair, with casters - Product Code INM
  • Reason
    Winco mfg., llc, ocala, florida is recalling their care cliner. due to malfunctioning axles which become lose from the caster assembly. this chair is a multi position recliner with a steel frame used primarily in clinics, hospitals and treatment centers for recovery, dialysis, oncology, examination, infusion. recalled chairs include the following: care cliner, xl care cliner, drop arm care cliner.
  • Action
    Winco sent an Urgent Device Recall letter dated October 1, 2010, to all customers. The letter identified the product, the problem, and the action to be taken by the customer. Replacement parts were sent out to the consignees and customers were asked to dispose of the defective casters. Any consignee not reponding by November 15, 2010, would receive an additional letter. The firm placed a follow up phone call to the non responding consignees after two weeks. Customers were advised to call 800-237-3377 or email customer service at customerservice@wincomfg.com with questions or concerns. For questions or concerns regarding this recall call 352-854-2929 x 110.

Device

Care Cliner
  • Model / Serial
    Recalled chairs include the following Models : Recalled chairs include the following:   2008 Model Numbers:  653N - Care Cliner, 654N - XL Care Cliner, 655N - Drop Arm Care Cliner, 657N - XL Drop Arm Care Cliner, 690N - Elite Care Cliner, 691N - XL Elite Care Cliner, 694N - Dual Swing-Arm Elite Care Cliner, 695N - XL Dual Swing-Arm Elite Care Cliner.   2009 Model Numbers:  6530 - Care Cliner, 6540 - XL Care Cliner, 6550 - Drop Arm Care Cliner, 6570- XL Drop Arm Care Cliner, 6900 - Elite Care Cliner, 6910 - XL Elite Care Cliner, 6940 - Dual Swing-Arm Elite Care Cliner, 6950 - XL Dual Swing-Arm Elite Care Cliner.  Recalled model numbers are as folows:  6530-02, 6530-03, 6530-03-TB, 6530-04, 6530-06, 6530-07, 6530-08, 6530-08-TB-00-PB, 6530-14, 6530-15, 6530-15-00-00-00-00-LC, 6530-15-00-00-PB, 6530-16, 6530-17, 6530-17-TB, 6530-25, 65302N,  65302NT,  6530-30, 6530-31, 6530-33, 6530-37-00-00-PB, 6530-39, 6530-39-00-00-PB, 65303N,  65303N,  65304N,  65304NH,  65304NHT,  65304NT,  6530-63, 6530-63-TB, 65306N,  65306NH,  65307N,  65307NT,  65308N,  65308NT,  65314N,  65314NH,  65314NT,  65315N,  65316N,  65317N,  65317NT,  65330N,  65333NT,  65337N,  65341N,  65344N,  65360N,  65361N,  65362N,  65362NT,  65363N,  65363NT,  6540-02, 6540-03, 6540-04, 6540-04-00-HM, 6540-06, 6540-07, 6540-08, 6540-14, 6540-16-TB, 6540-17, 6540-17-TB, 65402N,  65402NT,  6540-30-00-00-PB, 6540-37, 6540-39, 6540-39-00-00-PB, 65403N,  65403NT,  65404N,  65404NH,  65404NHT,  6540-60, 6540-63-TB, 65406N,  65406NH,  65407N,  65408N,  65414N,  65414NT,  65415N,  65416N,  65417N,  65417NT,  65430N,  65437N,  65441N,  65442N,  65461NH,  65462N,  65465N,  6550-02, 6550-03, 6550-03-00-HM, 6550-04, 6550-06, 6550-13, 6550-14, 6550-14-00-00-PB, 6550-14-00-HM, 6550-16, 6550-17, 65502N,  6550-30-00-HM, 6550-34-00-00-PB, 6550-37, 6550-39-00-HM, 65503N,  65503NH,  65504N,  65504NL,  65504NT,  65504NT-DART,  65506N,  65506NH,  65507N,  65507NH,  65508N,  65514N,  65514NH,  65514NL,  65514NW,  65515N,  65516N,  65516NH,  65516NT,  65517N,  65517NCE,  65517NH,  65517NHT,  65525N,  65527N,  65527NH,  65528NH,  65530NH,  65532N,  65532NH,  65533N,  65537N,  65539N,  65539NH,  65541NL,  65544NW,  65561NL,  65562NH,  65562NL,  65567N,  65567NH,  6570-02, 6570-03, 6570-03-00-HM, 6570-07, 6570-14, 6570-14-00-00-PB, 6570-14-00-HM, 6570-17, 6570-17-00-00-PB, 6570-17-00-00-PC, 6570-17-TB,  65702N,  65702NT,  6570-39-00-HM,  65703N,  65703NH,  6570-41,  65704N,  65704NT,  6570-62, 6570-63-TB,  65706N ,  65706NH,  65707N,  65707NH,  65708N,  65708NT,  65714N,  65714NH,  65714NL,  65714NT,  65714NW,  65715N,  65716NH,  65717N,  65717NCE,  65717NH,  65725N,  65727NH,  65728NH,  65730N,  65730NH,  65732N,  65732NH,  65733N,  65737N,  65739N,  65739NH,  65741NH,  65741NL,  65761N,  65762N,  65762NH,  65762NL,  65763NH,  65766N,  65767NH,  6900-02, 6900-03, 6900-04, 6900-17, 69002N ,  6900-30, 6900-39 ,  69003N,  69003NH,  6900-41,  69004N,  6900-60, 6900-61, 6900-62, 6900-63, 6900-63-00-HM, 6900-63-TB,  69006N,  69007N,  69008N,  69008NH,  69014N,  69014NT,  69014NW,  69015N,  69016N,  69016NT,  69017N,  69017NH,  69026N,  69027N,  69028N,  69030N,  69030NH,  69031N,  69032N,  69033N,  69034N,  69037N,  69039N,  69041N,  69041NH,  69060N,  69062N,  69063N,  69063NH,  69063NT,  69065NT,  69066N,  69066NT,  69067N,  6910-03, 6910-06, 6910-17, 6910-32, 6910-33-00-HM, 6910-37-00-00-PB, 6910-37-TB, 6910-39,  69103N,  69104N,  6910-60, 6910-61, 6910-62, 6910-63,  69106N,  69107NT,  69114N,  69114NW,  69117N,  69117NH,  69117NT,  69127N,  69133N,  69133NT,  69134N,  69137N,  69162N,  69163N,  69167N,  6940-03, 6940-03-00-HT, 6940-04-TB-HT, 6940-06, 6940-06-TB-HM, 6940-07-TB, 6940-14, 6940-14-TB, 6940-15, 6940-15-00-HM, 6940-16, 6940-16-TB-HM, 6940-17, 6940-17-00-HM, 6940-17-TB-HM, 6940-19-TB-HM, 6940-26-TB, 6940-26-TB-HM, 6940-27-TB-HM, 69402N,  69402NT,  6940-30, 6940-32, 6940-32-TB, 6940-33-TB-HM,  69403N,  69403NH,  69403NT,  69403NW,  6940-41-TB-HM,  69404N,  69404NDH,  69404NH,  69404NHT,  69404NT,  69404NWT,  6940-60-TB-HT, 6940-62, 6940-62-TB, 6940-62-TB-HM, 6940-62-TB-HT, 6940-63-TB, 69406N,  69406NH,  69407N ,  69407NT,  69414N,  69414NH,  69414NT,  69415N,  69415NH,  69415NHT,  69416N,  69416NHT,  69416NT,  69417N,  69417NHT,  69417NT,  69417NW,  69419NHT,  69427NHT,  69429NT,  69430NH,  69432N,  69432NT,  69433N,  69433NH,  69433NHT,  69433NT,  69434N,  69434NHT,  69437NH,  69437NHT,  69441NHT,  69444ND,  69444NDH,  69460N,  69460NHT,  69460NWT,  69461NH,  69462N,  69462NHT,  69462NT,  69463N,  69463NH,  69463NT,  69463NWT,  69466NWT,  69467N,  6950-03, 6950-03-00-HT, 6950-04-00-HM, 6950-04-TB-HT, 6950-06-TB-HM, 6950-15, 6950-16-TB-HM, 6950-19-TB-HM, 6950-19-TB-HT, 6950-26-TB-HM, 6950-27-TB-HM, 69502NH,  6950-33, 6950-33-TB-HM, 6950-39-00-HM,  69503N,  69503N,  69503NH,  69503NT,  6950-41-00-HT,  69504N,  69504NH,  69504NW,  6950-60, 6950-60-TB-HT, 6950-62-00-00-PB, 6950-62-TB-HT, 69506NHT,  69514N,  69514NH,  69514NHT,  69514NT,  69515N,  69515NH,  69516N,  69516NHT,  69516NT,  69517N,  69517NH,  69517NHT,  69517NT,  69519NHT,  69527NHT,  69529NT,  69530NH,  69532N,  69532NT,  69533N,  69533NH,  69533NHT,  69534N,  69541NHT,  69544ND,  69560N,  69560NHT,  69560NWT,  69561N,  69561NH,  69562N,  69562NHT,  69563NH,  69563NWT.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (all states except Vermont and Nebraska) and the countries of Belgium, Canada, Chile, Ireland, Kuwait, Netherlands, Saud Arabia, Singapore and United Arab Emirates.
  • Product Description
    Recalled chairs include the following: || 2008 Model Numbers: || 653N - Care Cliner, 654N - XL Care Cliner, 655N - Drop Arm Care Cliner, 657N - XL Drop Arm Care Cliner, 690N - Elite Care Cliner, || 691N - XL Elite Care Cliner, 694N - Dual Swing-Arm Elite Care Cliner, 695N - XL Dual Swing-Arm Elite Care Cliner. || 2009 Model Numbers: || 6530 - Care Cliner, 6540 - XL Care Cliner, 6550 - Drop Arm Care Cliner, 6570- XL Drop Arm Care Cliner, 6900 - Elite Care Cliner, 6910 - XL Elite Care Cliner, 6940 - Dual Swing-Arm Elite Care Cliner, 6950 - XL Dual Swing-Arm Elite Care Cliner.
  • Manufacturer
    Winco, Inc.

Manufacturer

Winco, Inc.
  • Manufacturer Address
    Winco, Inc., 5516 SW 1st Lane, Ocala FL 34474-9307
  • Manufacturer Parent Company (2017)
    Winco Inc
  • Source
    USFDA